cGMP Facilities

cGMP Purification Suites

In addition to research and process development laboratory, CBB provides cGMP fermentation and protein purification services for Phase 1 clinical trials. cGMP laboratory started its operations in 2007. All the critical equipment in the cGMP facilities have been qualified with Factory Acceptance Tests (FAT), IQ and OQ. Since 2007, CBB has successfully executed more than 50 campaigns. This has resulted in IND filing by a client.

The cGMP facilities offer state-of-the-art manufacturing with fully compliant documentation of equipment, operations and facilities. The facility is open for audit by clients. GMP equipment includes three B.Braun fermentors with 30, 100 and 300 liter capacity. The culture harvest is performed by Alfa-Laval disc-stack centrifuge. cGMP laboratory is equipped with an Avestin Homogenizer (Model C160) for cell breakage to recover intracellular products.

The downstream processing purification is conducted in an ISO Class 8 or one of two ISO Class 7 suites. The cGMP protein purification suite is equipped with AKTA chromotography systems such as a Process skid, Pilot and Purifier. CBB staff are highly skilled in isolation of inclusion bodies and refolding at a large scale (500 Liters).

CBB has similar equipment in both RPD and GMP facility, which makes technology transfer seamless. Typically, CBB develops robust processes in its existing RPD laboratory. After the development is complete, CBB in consultation with client finalizes documentation and transfers processes to the cGMP facility. This offers an efficient and economical approach to rapidly establishing a sound process on a cGMP platform.

A dedicated QA/QC group closely monitors the process to validate conformity to cGMP standards. CBB offers extensive documentation packages to its cGMP clients including the assistance in writing CMC sections. QA/QC activities are staffed with full time professionals trained in cGMP operations.

A professional staff fully trained in fermentation, large scale bioprocessing, and in cGMP regulations, provides efficient and timely services so that your product can reach the market quickly. Please contact CBB at biocatalysis@uiowa.edu for your cGMP requirements, or call 319-335-4900.